Outbreak Detection, Patient Protection: The Legal Upside of Genomics in Infection Prevention
A string of infections following routine knee surgeries in Tennessee has escalated into litigation, raising questions about how—and when—health care facilities should detect outbreaks. As genomic surveillance gains traction in infection prevention, some fear it could increase legal risk. In reality, it may offer hospitals their strongest legal defense.
Genomics
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In 2023, several patients underwent routine knee surgeries at Parkwest Surgery Center in Knoxville, Tennessee. As we previously shared in Infection Control Today®, those procedures were followed by persistent infections caused by Mycobacterium fortuitum, a non-tuberculous mycobacterium (NTM) linked to the surgical environment.1 Now, that outbreak is the subject of active litigation. Lawsuits allege the center failed to follow infection control protocols and continued operating despite signs of ongoing transmission.2
While the Parkwest case is still unfolding, it reflects a broader challenge: how can hospitals both detect and respond to outbreaks before they cause widespread harm—and legal exposure? Increasingly, health care systems are turning to more advanced tools to answer this question. Among them, pathogen genomics has emerged as a powerful way to detect transmission events early and accurately.3
Yet, as more hospitals explore using genomic surveillance—sequencing infections regardless of the suspicion of an outbreak—a recurring concern surfaces: Will detecting more outbreaks expose us to more lawsuits?
Based on my work and discussions with hospitals across the country, the short answer is: not if you act. In fact, genomic surveillance may prove to be one of the strongest shields against litigation when used proactively and ethically.
Proving Causation with Genomics
Historically, proving a direct link between a hospital’s environmental conditions and a patient’s infection has been challenging in court. Outbreaks often unfold subtly and over long periods. But pathogen genomics changes that calculus. By comparing pathogen genomes from patients, equipment, or the environment, genomics can determine whether infections likely originated from a common source. This powerful evidence can support—or refute—claims of nosocomial transmission.3
An example worth noting involves contaminated duodenoscopes, which were linked to superbug outbreaks in multiple U.S. hospitals during the 2010s. Though genomics wasn’t central to the lawsuits, outbreak investigations helped reveal that design flaws in the scopes—not hospital error—were likely responsible for the infections. Internal emails from the device manufacturer showed the company was aware of the contamination risks but delayed issuing warnings.4 In this case, strong investigative work and timely detection shifted liability from hospitals to the manufacturer, demonstrating how these tools can protect institutions when problems originate externally.
Genomic surveillance raises the evidentiary bar. It can help confirm that a hospital is not the source of an infection, or identify the route and stop transmission quickly, reducing harm and legal exposure.
Surveillance Is Not Negligence—Inaction Is
Detecting more outbreaks through genomic surveillance does not equate to more hospital negligence. Negligence stems from inaction, not detection. If your team identifies an outbreak through genomics and responds swiftly—enhancing cleaning, auditing practice, and notifying stakeholders—you are doing exactly what any reasonable infection preventionist is supposed to do.
In contrast, ignoring those signals—letting genetically linked infections spread without meaningful intervention—may increasingly be viewed as a breach of duty. As US courts grow more familiar with microbial forensics, failure to act on clear genomic and epidemiological evidence could be cited as a delayed or negligent response. Importantly, genomic data should never stand alone. Just as the FDA and CDC emphasize in outbreak investigations, sequencing results must be interpreted in the broader epidemiological context, considering time, place, and patient exposures to draw meaningful conclusions before action.5 This is why genomic surveillance should be viewed not as a risk but as a mitigation strategy. It provides earlier warning, more precise targets for intervention, and an evidence trail to demonstrate due diligence if a case ever arises.
Standard of Care Is Evolving
Currently, genomic surveillance is not a defined standard of care in the US. But we are moving in that direction. Imagine 2 hospitals: Hospital A uses genomic surveillance, identifies an emerging outbreak at 2 cases, and contains it. Hospital B does not use surveillance and has 15 infections before realizing a problem. If the pathogens in Hospital B are genetically identical and traceable to a common environmental source, plaintiffs may argue those infections—and possibly deaths—could have been prevented if Hospital B had adopted available surveillance tools.
If we go back to the Parkwest Surgery Center case, multiple cases were reported until the outbreak was detected. But what if the center had been performing sequencing on these infections as they unfolded? They may have been able to detect, intervene, and stop the outbreak earlier. This is how standards evolve: not overnight, but incrementally, through cases, peer-reviewed evidence, and professional expectations.
Reframing the Hesitation
So why the hesitation among hospitals? Often, it is rooted in a misconception: That finding more means you’re doing worse. In reality, the opposite may be true. Traditional infection prevention methods miss many outbreaks entirely. Genomics simply makes the invisible visible.
Studies from hospitals globally have shown that genomic surveillance detects many more outbreaks than traditional methods and that interventions stemming from these findings reduce infections and save costs.3 The hesitation should not be “What if we find more?” but rather, “What are we missing now—and what could it cost us later?”
What Does This Mean for Infection Preventionists?
As an infection preventionist, your role is to reduce harm, improve safety, and respond decisively to threats. Genomics gives you a sharper lens to do just that. It is not a liability. It amplifies your expertise.
Moreover, transparency and preparedness remain the best legal defense. If an outbreak occurs, being able to show that you had tools in place to detect and intervene—not just react—strengthens your position with regulators, patients, and even courts. Hospitals should not wait for genomics to be mandated before beginning to build capacity. Early adopters are already shaping the expectations of what responsible, modern infection prevention looks like.
We may not be able to prevent every infection. But we can prevent many from spreading undetected. Genomic surveillance is not a legal threat—it is a legal safeguard. When paired with strong infection control and prevention protocols, it becomes a vital part of the patient safety ecosystem. Genomic surveillance is not about creating new problems, but it’s about catching the ones we’ve been missing.
The views expressed here are my own and do not reflect those of any institution with which I am affiliated. This commentary is not intended as legal advice.
References
1.Sundermann A. Non-tuberculous Mycobacterium Outbreak at Surgery Center Highlights Infection Control Lapses. Infection Control Today. May 13, 2025. Accessed May 15, 2025. https://www.infectioncontroltoday.com/view/non-tuberculous-mycobacterium-outbreak-surgery-center-highlights-infection-control-lapses
2.10Investigates: Surgery center faces lawsuits over infections following 2023 procedures. wbir.com. May 7, 2025. Accessed May 15, 2025. https://www.wbir.com/article/news/local/parkwest-surgery-center-faces-lawsuits-over-infections/51-7daf1a25-bcee-41b7-becd-fdb222ebccc9
3.Sundermann AJ, Rosa R, Harris PNA, et al. Pathogen genomics in healthcare: overcoming barriers to proactive surveillance. Antimicrob Agents Chemother. 2024;69(1):e01479-24. doi:10.1128/aac.01479-24
4.Terhune C. Olympus Told U.S. Executives No Broad Scope Warning Needed Despite Superbug Outbreaks. KFF Health News. July 24, 2016. Accessed May 15, 2025. https://kffhealthnews.org/news/device-maker-told-its-u-s-operation-no-warning-needed-on-scope-contamination-risk/
5.Brown E, Dessai U, McGarry S, Gerner-Smidt P. Use of Whole-Genome Sequencing for Food Safety and Public Health in the United States. Foodborne Pathog Dis. 2019;16(7):441-450. doi:10.1089/fpd.2019.2662
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